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By Tony Dutra
The American Civil Liberties Union and the Public Patent Foundation filed the much anticipated certiorari petition Dec. 7, asking the U.S. Supreme Court to take up the question of whether patents on genetic materials are statutory subject matter under 35 U.S.C. §101 (Association for Molecular Pathology v. Myriad Genetics Inc.U.S., No. not available, review sought 12/7/11).
The organizations, acting on behalf of challengers to gene patents asserted by Myriad Genetics Inc., asked the high court to overturn the July 29 split decision of the U.S. Court of Appeals for the Federal Circuit upholding patent eligibility. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011) (147 PTD, 8/1/11).
The petition also asked the court to reverse the Federal Circuit's opinion as to the requirements for standing in the case. The appeals court held that only one plaintiff—out of several medical associations, medical researchers, breast cancer counselors, and women diagnosed with or seeking diagnosis—had standing.
The petitioners did not challenge the ruling below that one method claim at issue was patent eligible under Section 101.
The case involves a 2009 declaratory judgment challenge initiated by the ACLU and PUBPAT against patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) for which Myriad is the exclusive licensee (91 PTD, 5/14/09).
The plaintiffs argued that nine composition of matter and six method claims of the patents—on the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer—were ineligible for patenting under Section 101.
The three panel judges agreed that only one of the method claims at issue was drawn to patentable subject matter, and that claims to cDNA are patent eligible.
They split 2-1, however, as to claims to isolated DNA, with the majority reversing the lower court's ruling against patent eligibility for such claims. No. 09 Civ. 4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010) (60 PTD, 3/31/10).
Judge Alan D. Lourie wrote the majority opinion; Judge Kimberly A. Moore wrote a concurrence. They agreed at minimum that isolated DNA has “markedly different chemical characteristics” compared to corresponding native DNA in the human body, reciting the court's standard set in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980).
However, they identified different standards for distinguishing patent-ineligible “products of nature.” In dissent, Judge William C. Bryson described yet another approach.
The en banc court rejected the both parties' rehearing petitions.
The ACLU's Christopher A. Hansen, New York, argued before the Federal Circuit and is counsel of record on the petition. Two questions are presented, one on the DNA claim challenge and one on standing.
The question presented as to the isolated DNA patent eligibility holding is simply, “Are human genes patentable?”
The petitioners attacked the Section 101 ruling by the appeals court both on doctrinal and policy grounds.
First, the petition broadened the scope of the challenge to date slightly, focusing on the Section 101 requirement of a “new and useful” composition of matter. The ACLU thus concluded that the “useful” requirement meant that the function of the isolated DNA—not just its chemical structure—must be markedly different from what appears in the human body.
Even as to structure, the petitioners sought to isolate Lourie's opinion, contending that the other two members of the Federal Circuit panel and District Court Judge Robert W. Sweet all ruled “that ‘isolated' genes were virtually identical structurally to genes in the body.”
The ACLU also claimed support from the government, citing the Department of Justice's unsolicited brief filed in the Federal Circuit, though it noted that, “Contrary to the usual practice, the [Patent and Trademark Office] did not sign the brief.”
Turning to its policy arguments, the ACLU began, “At its core, [this case] presents a critical question of great concern to this country, especially patients affected by hereditary breast and ovarian cancer and the medical and scientific communities: are patents on genes valid, thus preventing advances in science and medicine that could result in better diagnosis and treatment?”
It then cited the support of multiple amici who filed briefs supporting the appellants in the appeals court.
Further, the petition claimed, “The usual rationale for granting a patent—the need to create economic incentives to advance science—did not apply in this case and does not apply to products of nature.” Indeed, it argued that the scientific community was well on its way to the discoveries claimed by Myriad and they “would have been made available to the public even without the patent incentive.”
Finally, the plaintiffs reprised an argument that had initially been brought against the PTO as a separate defendant: “Patents on isolated DNA, whether small segments or whole genes, also violate the First Amendment because they block scientific inquiry into the patented DNA.”
The petitioners contended that DNA patents “grant control over a body of knowledge and pure information.”
The standing question arises despite the fact that the appeals court reached the merits.
The panel ruled that only one plaintiff—Harry Ostrer, a researcher at New York University School of Medicine—met the requirements for declaratory judgment standing under the Supreme Court's decision in MedImmune Inc. v. Genentech Inc., 549 U.S. 118, 81 USPQ2d 1225 (2007) (6 PTD, 01/10/07) —“a substantial controversy … of sufficient immediacy and reality” and “meaningful preparation” to conduct potentially infringing activity.
However, just before the Federal Circuit's July 29 decision, Myriad notified the court that Ostrer was planning to leave NYU at the end of August and move to the Montefiore Medical Center at the Albert Einstein College of Medicine, thereby putting his standing in doubt for lack of a continuing controversy.
The ACLU countered, submitting a letter to the court asserting that Ostrer still has a “wish to engage in sequencing” BRCA 1 and 2 at Montefiore. The court did not discuss either communication in its opinion.
The en banc Federal Circuit denied Myriad's rehearing petition as to Ostrer's status.
The ACLU's rehearing petition did not address Myriad's concern, but instead made a case for standing for two other plaintiffs. Its certiorari petition repeated those arguments.
First, the ACLU argued, if Ostrer has standing, an organization for which he is a member—the American College of Medical Genetics—has organizational standing under Warth v. Selden, 422 U.S. 490, 511 (1975).
Second, the petition countered the court's assertion that only Ostrer and two other researchers had received threatening communications from Myriad. Another plaintiff, Ellen Matloff, declared that “she personally had conversations with Myriad in which she was told by Myriad that she and geneticists at Yale would violate Myriad's patents if they performed the tests that she wanted to perform,” the ACLU said.
But ultimately, the petitioners sought a further expansion of eligibility for standing. They contended that the Federal Circuit imposed a “new and inflexible rule” contrary to the Supreme Court's flexible approach under MedImmune. They cited the appeals court's decision for “the idea that a plaintiff cannot have standing unless a patent holder ‘directed any letters or other communications regarding its patents at them.' ”
Such a rule “is contrary to numerous decisions of this Court that parties may bring challenges even if they have not been personally threatened by those who enforce the requirement they seek to challenge,” the petition argued.
The petitioners did not mention the question related to Ostrer's move to Montefiore. However, they addressed the second part of the Federal Circuit's standing requirement—“meaningful preparation” to conduct potentially infringing activity—as to those were indirectly threatened by their knowledge of Myriad's enforcement activities.
“The medical organizational plaintiffs and most of the physician plaintiffs would be identical for standing purposes to Dr. Ostrer, because they have the equipment, expertise and desire to engage in testing but have refrained solely as a result of Myriad's repeated suits and threats,” the petitioners claimed.
Gregory A. Castanias of Jones Day, Washington, D.C., represents Myriad.
Rep. Louise Slaughter (D-N.Y.), on Dec. 7 sent a letter to Solicitor General Donald Verrilli, urging the government to support Supreme Court review in the case, according to a press statement from her office.
Slaughter is the only microbiologist in Congress and is the author of the Genetic Information Nondiscrimination Act, enacted in 2008 to prevent health insurers from canceling or changing coverage based solely on a genetic predisposition toward a specific disease, and to bar employers from using an individual's genetic information when making employment-related decisions.
According to Slaughter, gene patenting holds back medical breakthroughs and is fundamentally at odds with the purpose of the Patent and Trademark Office. “We cannot reap the full benefits of personalized medicine if researchers must each time go to patent holders in order to analyze a patient's DNA,” she said in her letter.
The patent system “was not meant to cover parts of the human body or the natural world,” Slaughter said, adding that the gene patenting has been particularly harmful to women. “We're sitting on the edge of countless scientific breakthroughs and letting the patenting of genes get in the way of saving lives,” she said. “We need a ruling from the Supreme Court and the help of Solicitor General so we can unleash the ingenuity that will move science forward,” she asserted.
Petition at http://pub.bna.com/ptcj/MyriadCertPetDec7.pdf
Federal Circuit opinion at http://pub.bna.com/ptcj/101406July29.pdf
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